“Developing a robust process to produce a monoclonal antibody [mAb] is always complex,” Alain Lamproye, President of Novasep’s Biopharma business told Biopharma-Reporter. “It requires much expertise in both upstream and downstream processing, as well as high-level expertise in adjacent technologies, such as cell line characterization and analytics.”
He added there are further complications due to small scale production being very different from larger scale production.
Therefore, his company has teamed up with fellow bioprocessing services firm GTP Technology to offer European mAb developers a “fast-track process development” service, combining GTP’s proof-of-concept and early clinical stage capabilities with Novasep’s late stage production network.
“The partnership enables an end-to-end solution for mAb production. Both teams will share their skills and expertise to better support their customers in developing efficient processes and scale up production.”
Novasep and GTP already share a number of the same customers and this partnership will speed their projects along, Lamproye added.
MAB contract manufacturing
He also told us the number of mAbs now in development is making biotech firms develop innovative therapeutic strategies to get their product on the market as soon as possible. “This is driving their desire to have a CMO develop their mAb production process from A to Z.”
Growing numbers of mAbs in development and the need to outsource production was discussed at last week’s Drug, Chemical & Associated Technologies Association (DCAT) meeting in New York.
Patti Seymour from Bioprocess Technology Consultants told delegates more than 900 biopharma products are in clinical development in the US and EU, with around 70% of these being mAbs.
William Downey, President of HighTech Business Decisions, added the resulting large demand for mammalian cell culture was driving the biopharma contract manufacturing market, which he said had been is projected to reach $3.1bn by the end of 2016.
With the growing demand for CMOs, Downey said that the companies are expanding their service offerings, predicted this trend to continue through more consolidation and partnership arrangements, as well as increasing use of disposable technologies and faster-turn-arounds.